MAUDE Adverse Event Report: IMRIS MRI ANTERIOR COIL

Device Problems Nonstandard Device (1420); Appropriate Term/Code Not Available (3191)

Patient Problems Erythema (1840); Partial thickness (Second Degree) Burn (2694)

Event Date 02/13/2019

Event Type  Injury  

Event Description

The patient was in the post anesthesia care unit (pacu) immediately after surgery and a reddened area was noted on his left lateral mid-forearm.A cold compress was applied.The site was assessed within the hour, while the patient remained in the pacu and the site had a hard area and formed a dime-sized blister in the middle of the wound.Manufacturer response for mri anterior coil, mri anterior coil (per site reporter).The mri director was alerted to this patient burn.He deployed the imaging physicists immediately to review the specific absorption rate (sar) values for this mri machine and concluded that the sar is below fda safety limits.The technologists confirmed that normal sar was applied during the study.The anterior coil was removed from the mri and the vendor, imris, has retrieved the coil and is completing testing of the coil.Our imris engineer has been involved with the follow-up.The coils have been swapped out previously due to element failure, which is normal maintenance.

• Brand Name: MRI ANTERIOR COIL
• Type of Device: MRI ANTERIOR COIL
• Manufacturer (Section D): IMRIS; deerfield imaging; 5101 shady oak road; minnetonka MN 55343
• MDR Report Key: 8590861
• MDR Text Key: 144467023
• Report Number: 8590861
• Device Sequence Number: 1
• Product Code: LNH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/25/2019,02/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/08/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/19/2019
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/25/2019
• Device Age: 4 YR
• Event Location: Hospital
• Date Report to Manufacturer: 05/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 9125 DA
• Patient Weight: 132